GXO · Strip, Craniosynostosis, Preformed
Neurology · 21 CFR 882.5900 · Class 2
Overview
| Product Code | GXO |
|---|---|
| Device Name | Strip, Craniosynostosis, Preformed |
| Regulation | 21 CFR 882.5900 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| Implant | Yes |
Identification
A preformed craniosynostosis strip is a plastic strip used to cover bone edges of craniectomy sites (sites where the skull has been cut) to prevent the bone from regrowing in patients whose skull sutures are abnormally fused together.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K033395 | CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1 | Codman & Shurtleff, Inc. | Feb 25, 2004 | SESE |
| K961802 | PRECLUDE SYNBLOC MEMBRANE | W. L. Gore & Associates, Inc. | Jul 31, 1996 | SESE |
Top Applicants
- Codman & Shurtleff, Inc. — 1 clearance
- W. L. Gore & Associates, Inc. — 1 clearance
